In setback for Ebola vaccine, company says work will take longer than hoped

The Ebola crisis took new twists Friday, with another somber update from the World Health Organization on the outbreak in West Africa and a bleak warning from a major drug manufacturer that a safe vaccine likely won’t be ready before the current epidemic has passed.

Dr. Ripley Ballou, head of Ebola research for Great Britain’s GlaxoSmithKline, told the BBC that full data on a vaccine’s safety and efficacy won’t be ready until late 2015, and full-scale production for general use won’t happen until well into 2016.

The World Health Organization had said a month ago that it hoped data from clinical trials on two vaccines would be available by next month, and the vaccines would be available for use by health care workers by January.

GlaxoSmithKline’s Ebola CAd3 vaccine was one of the two vaccines. The other was the VSV vaccine, made by NewLink Genetics Corp., which is headquartered in Ames, Iowa. The GlaxoSmithKline vaccine has been developed in collaboration with the U.S. National Institute of Allergy and Infectious Diseases.

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Ballou’s assessment alarmed experts at the the medical charity Doctors without Borders, which has more than 3,000 staff members fighting the epidemic in the three most affected countries, Liberia, Sierra Leone and Guinea. The organization, at least 16 of whose workers have contracted the disease, urged GlaxoSmithKline to step up its efforts.

“This is a disaster scenario,” the organization’s executive director for drug access, Manica Balasegaram, told McClatchy. “We want to see serious acceleration. We need to be more ambitious. It’s worrying to hear timelines into 2016. We have got to accelerate. The situation on the ground is a catastrophe.”

He said Doctors Without Borders has 60 centers in the affected countries, and so far it had treated more than 4,500 victims.

Catherine Hartley, a GlaxoSmithKline spokewoman, told McClatchy the drug company is working as fast as it can. She said the company already has begun manufacturing 10,000 doses of the vaccine so that it can move quickly to the second stage of clinical trials if the first ones are successful. Information on those first-phase trials will be available early next year.

The second-phase trials will include “high risk populations, such as front-line health workers,” and should begin in 2015, she said. In the meantime, GlaxoSmithKline is trying to speed up preparations for “manufacturing at an industrial scale so that if the trials are successful, we will be in position to significantly ramp up production to help combat this or future Ebola outbreaks.”

EDITORS: END OPTIONAL TRIM

The bad news on the vaccination front came as WHO published its latest update on the progress of the epidemic. It said that as of Tuesday, Ebola has been detected in seven countries, including the United States and Spain, and that 219 more infections had been reported since the last report was released two days ago, bringing to 9,216 the total number of cases reported so far. Of those, 4,555 people have died.

The new report added three to the number of medical workers who’ve died from Ebola, bringing that number to 239.

One bright spot was the declaration that Senegal is now considered Ebola free. The country had reported a single case of Ebola infection in August; 42 days later, that person is now virus free.

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